Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 15, 2025

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2030

Conditions
Microtia, CongenitalMicrotiaMicrotia-AnotiaEar Deformities, AcquiredEar Deformity ExternalEar MalformationEar Cartilage
Interventions
PROCEDURE

Use of AuryzoN™ EAR 2.0 device

AuryzoN™ EAR 2.0 is an investigational non-significant risk device developed to improve cartilage construct shape and stability prior to use in ear reconstructive surgery.

PROCEDURE

Hand carving

Standard hand carving using standard surgical blades will be performed in this intervention arm of the study.

Trial Locations (1)

32827

RECRUITING

Nemours Children's Hospital, Florida, Orlando

All Listed Sponsors
lead

Nemours Children's Clinic

OTHER